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SSRIs (PAXIL®, PROZAC®, ZOLOFT®)

Selective Serotonin Reuptake Inhibitors (SSRIs) and Persistent Pulmonary Hypertension (PPHN) in Newborns: The New England Journal of Medicine recently published a study that showed that babies born to mothers who took Selective Serotonin Reuptake Inhibitors (SSRIs) such as Paxil®, Prozac®, and Zoloft® during pregnancy had a significantly increased risk of being born with Persistent Pulmonary Hypertension (PPHN). PPHN is a very serious respiratory disorder that is a failure of the normal circulatory transition that occurs after birth and which limits the newborn’s ability to provide itself with an adequate supply of oxygen-rich blood.

Data from this study indicate that the use of SSRIs during the second half of pregnancy may increase the risk of PPHN by as much as six times the normal risk. Historically, PPHN occurs in one to two infants per 1000 live births. However, data from this study suggest that when SSRIs are used during the second half of pregnancy, the rate of PPHN increases to five to six cases per 1000 live births.

Paxil® and the Risk of Infant Heart Defects: The U.S. Food and Drug Administration (FDA), on December 8, 2005, issued a Public Health Advisory in which it announced the results of two studies that examined the effects of Paxil® (paroxetine) use by pregnant women during the first trimester (first three months) of pregnancy. One study, which gathered data from the Swedish national registry, concluded that women who took Paxil® during the first three months of pregnancy doubled the risk that their babies would be both with a heart (cardiac) defect. In the second study, researchers examined a U.S. insurance claims database and concluded that babies whose mothers took Paxil® during the first trimester of pregnancy had a 50% greater risk of developing a cardiac malformation than babies whose mothers did not take Paxil® during the same time period.

The most common heart defects identified in the studies were atrial and ventricular septal defects, which are conditions in which the wall between the right and left sides of the heart is not completely developed. A ventricular septal defect (VSD) is a defect in the wall dividing the left and right ventricles of the heart. An atrial septal defect (ASD) involves the inter-atrial septum of the heart. These types of defects can range in severity from small defects that may resolve without treatment, to larger defects that require repair surgery.

Our firm has filed some of the first cases in the nation for injuries to infants described above. If you or a loved one has had a baby who has suffered from a cardiac defect, and the mother was on Paxil® at the time of her pregnancy, feel free to contact us for a case evaluation, to determine your rights to a potential lawsuit.

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